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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K130499
Device Name IU22 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell,  WA  98021 8431
Original Contact jessica stenberg
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/26/2013
Decision Date 06/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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